NCT02870478

Brief Summary

The purpose of this study is to determine whether less frequent dosing of atropine drops may be as effective as daily dosing for the treatment of progressive myopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3.4 years

First QC Date

July 27, 2016

Last Update Submit

November 2, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Change in pupil size at 1 week

    Measured at baseline and again 1 week after first using drop

Study Arms (2)

0.01% atropine daily

ACTIVE COMPARATOR

Nightly dosing of 0.01% atropine

Drug: Atropine

0.01% atropine twice per week

EXPERIMENTAL

Atropine dosed twice per week

Drug: Atropine

Interventions

AtropineDRUG

Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy

Also known as: atropine sulfate ophthalmic solution
0.01% atropine daily0.01% atropine twice per week

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must have vision that is correctable to 20/20 in each eye
  • Participants must also have normal binocular vision (no history of manifest eye turns or eye surgeries to correct an eye turn)
  • Participants must have normal accommodation (amplitude and facility within a normal range based on the subject's age)
  • Participants must have normal ocular health

You may not qualify if:

  • Previous chronic use of atropine
  • Participants who are pregnant, plan to become pregnant, or are breastfeeding
  • Sensitivity or allergy to atropine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Berkeley, Department of Vision Science

Berkeley, California, 94720-2020, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Maria Liu, OD, MPH, PhD

    UC Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 17, 2016

Study Start

July 1, 2016

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(1)